Medication shortages are nothing new, but the past few years have been particularly challenging, thanks to the COVID pandemic and other supply-chain disruptions. Patients had already been warned that a number of different drugs could be harder to find this year, including ADHD medications, chemotherapy treatments, weight-loss drugs, and antibiotics. And now, the Centers for Disease Control and Prevention (CDC) is alerting patients to a new problem that could worsen medication shortages before they get better.
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The CDC issued a Health Alert Network (HAN) Health Advisory on June 13 to warn about "potential disrupted access to care among individuals taking prescription stimulant medications."
Stimulants are most commonly prescribed for ADHD, and these medications have been facing significant shortages over the last two years. In Oct. 2022, the U.S. Food and Drug Administration (FDA) first announced that immediate release formulation of amphetamine mixed salts, also known as Adderall or Adderall IR, was in short supply.
Since then, the agency has added other commonly prescribed ADHD medications to its Drug Shortages List, including Focalin, Ritalin, and Vyvanse, according to Medscape Medical News.
"Not a day goes by when I don't hear from a number of unfortunately struggling patients about this shortage," Aditya Pawar, MD, a child and adolescent psychiatrist with the Kennedy Krieger Institute and an assistant professor of psychiatry and behavioral sciences at Johns Hopkins School of Medicine, told the news outlet in March.
In May, the FDA indicated that many of the ADHD medication shortages plaguing the U.S. had started to resolve, NBC News reported. At that point, a total of nine manufacturers had these drugs back in stock, and a spokesperson for the FDA said that the agency expected additional supply to be returning to normal over the next few months.
"The public should rest assured the FDA is working closely with numerous manufacturers and others in the supply chain to understand, mitigate and prevent or reduce the impact of intermittent or reduced availability of certain products,” the spokesperson told NBC News.
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But there may be another impediment after two executives from the telehealth startup Done were arrested. In its Health Advisory, the CDC explained that the U.S. Department of Justice (DOJ) had announced a federal health care fraud indictment against the "large subscription-based telehealth company that provides attention-deficit/hyperactivity disorder (ADHD) treatment to patients ages 18 years and older across the United States."
"As alleged, these defendants exploited the COVID-19 pandemic to develop and carry out a $100 million scheme to defraud taxpayers and provide easy access to Adderall and other stimulants for no legitimate medical purpose," Attorney General Merrick B. Garland said in a statement.
Done said it "disagrees with the criminal charges" filed against its founders, and added that the company "will continue to operate—and do everything in our power to ensure that the more than tens of thousands Americans that rely on us do not lose access to their mental health care."
But in the meantime, the CDC cautioned that "patients who rely on prescription stimulant medications to treat their ADHD and have been using this or other similar subscription-based telehealth platforms could experience a disruption to their treatment and disrupted access to care."
It is estimated that as many as 30,000 to 50,000 adults across the U.S. may be impacted by this indictment, according to the agency.
"This potential disruption coincides with an ongoing prescription drug shortage involving several stimulant medications commonly prescribed to treat ADHD," the CDC stated in its alert. "Patients whose care or access to prescription stimulant medications is disrupted, and who seek medication outside of the regulated healthcare system, might significantly increase their risk of overdose due to the prevalence of counterfeit pills in the illegal drug market that could contain unexpected substances, including fentanyl."